DDMAC regulatory letters could double in 2010

New Year's Eve is five months away, but FDA letter-writers have already been prolific in 2010 on themes of risk omission, inflated efficacy claims, and unfair balance presentation as seen in promotional materials targeting physicians and consumers.

So far, FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) has sent out 40 enforcement letters – 30 Untitled Letters and 10 Warning Letters – in 2010, compared with a total of 41 enforcement letters – 28 Untitled Letters and 13 Warning Letters – in all of 2009, according to Karen Mahoney, an FDA spokesperson. In 2008, DDMAC sent just 21 enforcement letters, 11 of which were Warning Letters.

“The increase in the number of regulatory letters are the result of DDMAC putting more resources into enforcement, and the FDA Enforcement Initiative announced by Commissioner [Margaret] Hamburg” last August, said Ayse Yeaton, an FDA spokesperson, adding that the agency has also streamlined its review process for regulatory letters. “This is positive for DDMAC's public health mission, as we are able to stop more misleading promotion,” said Yeaton.

Typically, Warning Letters are more severe than Untitled Letters, although both types usually ask that recipients immediately cease the dissemination of violative promotional materials. Since 2005, Warning Letters have also requested “corrective” messaging from advertisers, or “a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed,” to be sent to any “audience(s) that received the violative promotional materials.” Although Warning Letters do not assess direct financial penalties, drug-makers do take a hit in the wallet through the retraction (and correction) of a campaign.

Arnie Friede, an FDA legal expert and former attorney at Pfizer, said “People [in the pharmaceutical industry] aren't paying attention to these letters. We're seeing repeated instances of the same kinds of violations,” such as non-disclosure of risk information and unsubstantiated efficacy claims. “They're either not paying attention, or they're not absorbing the lessons in the letters,” said Friede. “How far up against the wall will industry push the FDA before [increasingly severe] actions are taken?”